Type2 DiabetesNCT03553862
Collaborative Care Model on Type 2 Diabetic Patients
A study testing collaborative care in people with Type2 Diabetes, run by National University of Singapore at 1 site in Singapore.
Trial summary
The purpose of this study is to determine the effectiveness of the collaborative care model in Singapore in which clinical pharmacists, nurses and dietitians are active participants who collaborate with physicians in caring for patients with Type 2 diabetes mellitus (DM).Since DM is a cardiovascular risk equivalent… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- collaborative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteSingapore
- Study dates
- 11 May 2018to 2 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 21 years with Type 2 DM (HbA1c > 7%) and polypharmacy (≥ 5 medications) will be eligible for this study.
Who cannot join
- Patients with Type 1 DM or who are unable to communicate independently in English, Chinese or Malay will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Collaborative Care Model in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore
The purpose of this study is to determine the effectiveness of the collaborative care model in Singapore in which clinical pharmacists, nurses and dietitians are active participants who collaborate with physicians in caring for patients with Type 2 diabetes mellitus (DM).Since DM is a cardiovascular risk equivalent, co-morbidities such as hypertension (HTN) and dyslipidaemia (DLP) will also be evaluated to assess the holistic care provided for the investigator's patients afflicted with these top chronic diseases in Singapore.
Read the detailed description
Specifically, this study aims to evaluate the effectiveness of an integrated collaborative care model comprising of a healthcare team (physician, clinical pharmacist, nurse, and/or dietitian) compared to the usual or conventional healthcare model (physician-centered care) mainly in the clinical, humanistic and economic outcomes.
- Conditions
- Type2 Diabetes
- Being tested
- collaborative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collaborative careBehavioural
The intervention arm will receive collaborative care from a team of healthcare professionals that consists of pharmacist, physicians, nurses and dietitians. Patients in the intervention group will also receive clinical interventions carried out by the pharmacist.nurses and dietitians as well as a pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients randomly assigned to the control arm will receive the usual or conventional care not interfered by the study team. |
| Intervention | Experimental | The intervention arm will receive collaborative care from a team of healthcare professionals that consists of pharmacist, physicians, nurses and dietitians. Patients in the intervention group will also receive clinical interventions carried out by the pharmacist. Receives: Behavioral: collaborative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Body mass index (BMI) at 6-month
Change of BMI in kg/m^2
Measured: baseline and 6-month
Change from baseline Glycated Haemoglobin (HbA1c) at 6-month
Change of HbA1c in %
Measured: baseline and 6-month
Changes from baseline Systolic Blood Pressure (SBP) at 6-month
Change of SBP in mmHg
Measured: baseline and 6-month
Change from baseline Low-density lipoprotein (LDL) at 6-month
Change of LDL in mg/dL
Measured: baseline and 6-month
Change from baseline High-density lipoprotein (HDL) at 6-month
Change of HDL in mg/dL
Measured: baseline and 6-month
Change from baseline Total cholesterol (TC) at 6-month
Change of TC in mg/dL
Measured: baseline and 6-month
Change from baseline Glycerides (TG) at 6-month
Changes of TG in mg/dL
Measured: baseline and 6-month
Incidence of hypoglycaemia
Incidence of hypoglycaemia
Measured: 6-month
Change from baseline Body mass index (BMI) at 12 months
Change BMI in kg/m^2
Measured: 12-month
Change from baseline Glycated Haemoglobin (HbA1c) at 12-month
Changes of HbA1c in %
Measured: 12-month
Change from baseline Systolic Blood Pressure (SBP) at 12-month
Change of SBP in mmHg
Measured: 12-month
Change from baseline Low-density lipoprotein (LDL) at 12-month
Changes of LDL in mg/dL
Measured: 12-month
Change from baseline High-density lipoprotein (HDL) at 12-month
Changes of HDL in mg/dL
Measured: 12-month
Change from baseline Total cholesterol (TC) at 12-month
Changes of TC in mg/dL
Measured: 12-month
Change from baseline Glycerides (TG) at 12-month
Changes of TG in mg/dL
Measured: 12-month
Incidence of hypoglycaemia
Incidence of hypoglycaemia
Measured: 12-month
Secondary outcomes (17)
The 5-level EQ-5D version (5Q-5D-5L)
5Q-5D-5L is a questionnaire containing 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) for the patients to indicate their health stage.
Measured: baseline
The 5-level EQ-5D version (5Q-5D-5L)
5Q-5D-5L is a questionnaire containing 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) for the patients to indicate their health stage.
Measured: 6-month
The 5-level EQ-5D version (5Q-5D-5L)
5Q-5D-5L is a questionnaire containing 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) for the patients to indicate their health stage.
Measured: 12-month
Audit of Diabetes Dependent Quality of Life (ADDQoL)
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
Measured: baseline
Audit of Diabetes Dependent Quality of Life (ADDQoL)
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
Measured: 6-month
Audit of Diabetes Dependent Quality of Life (ADDQoL)
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
Measured: 12-month
The Problem Area in Diabetes (PAID)
The PAID is a valid and reliable 20-item questionnaire measuring diabetes-related distress with a five-point Likert scale that ranges from 0 (not a problem) to 4 (serious problem).
Measured: baseline
The Problem Area in Diabetes (PAID)
The PAID is a valid and reliable 20-item questionnaire measuring diabetes-related distress with a five-point Likert scale that ranges from 0 (not a problem) to 4 (serious problem).
Measured: 6-month
The Problem Area in Diabetes (PAID)
The PAID is a valid and reliable 20-item questionnaire measuring diabetes-related distress with a five-point Likert scale that ranges from 0 (not a problem) to 4 (serious problem).
Measured: 12-month
Summary of Diabetes Self-Care Activities (SDSCA)
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes 14 items assessing the following aspects of the diabetes regimen: general dies, specific diet, exercise, blood-glucose testing, foot care, and smoking.
Measured: baseline
Summary of Diabetes Self-Care Activities (SDSCA)
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes 14 items assessing the following aspects of the diabetes regimen: general dies, specific diet, exercise, blood-glucose testing, foot care, and smoking.
Measured: 6-month
Summary of Diabetes Self-Care Activities (SDSCA)
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes 14 items assessing the following aspects of the diabetes regimen: general dies, specific diet, exercise, blood-glucose testing, foot care, and smoking.
Measured: 12-month
Self-report Hypoglycaemia Question
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Measured: baseline
Self-report Hypoglycaemia Question
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Measured: 6-month
Self-report Hypoglycaemia Question
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Measured: 12-month
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
The WPAI-GH is a 6-item questionnaire measuring absenteeism, presenteeism, overall work productivity loss, and daily activity impairment with a 10-point scale that range from 0 (no effect on daily activities) to 10 (serious effect on daily activities).
Measured: 6-month
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
The WPAI-GH is a 6-item questionnaire measuring absenteeism, presenteeism, overall work productivity loss, and daily activity impairment with a 10-point scale that range from 0 (no effect on daily activities) to 10 (serious effect on daily activities).
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start11 May 2018
- Primary completion14 Mar 2020
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce Lee, PharmD, National University of Singapore
- Investigators
- Wei Yan Tan, Principal investigator, National Healthcare Group Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553862
- Sponsor's protocol ID
- 2017/01191
- Other IDs
- 2017
- Status last verified
- Mar 2021
- First submitted
- 9 May 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siaw MYL, Ko Y, Malone DC, Tsou KYK, Lew YJ, Foo D, Tan E, Chan SC, Chia A, Sinaram SS, Goh KC, Lee JY. Impact of pharmacist-involved collaborative care on the clinical, humanistic and cost outcomes of high-risk patients with type 2 diabetes (IMPACT): a randomized controlled trial. J Clin Pharm Ther. 2017 Aug;42(4):475-482. doi: 10.1111/jcpt.12536. Epub 2017 Apr 27.
PubMed 28449205Jarab AS, Alqudah SG, Mukattash TL, Shattat G, Al-Qirim T. Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan. J Manag Care Pharm. 2012 Sep;18(7):516-26. doi: 10.18553/jmcp.2012.18.7.516.
PubMed 22971205Scott DM, Boyd ST, Stephan M, Augustine SC, Reardon TP. Outcomes of pharmacist-managed diabetes care services in a community health center. Am J Health Syst Pharm. 2006 Nov 1;63(21):2116-22. doi: 10.2146/ajhp060040.
PubMed 17057049Taylor KI, Oberle KM, Crutcher RA, Norton PG. Promoting health in type 2 diabetes: nurse-physician collaboration in primary care. Biol Res Nurs. 2005 Jan;6(3):207-15. doi: 10.1177/1099800404272223.
PubMed 15583361
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Collaborative Care Model in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore
- ClinicalTrials.gov ID
- NCT03553862
- Acronym / sponsor ID
- 2017/01191
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 11 May 2018 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of the collaborative care model in Singapore in which clinical pharmacists, nurses and dietitians are active participants who collaborate with physicians in caring for patients with Type 2 diabetes mellitus (DM).Since DM is a cardiovascular risk equivalent, co-morbidities such as hypertension (HTN) and dyslipidaemia (DLP) will also be evaluated to assess the holistic care provided for the investigator's patients afflicted with these top chronic diseases in Singapore.
Detailed description
Specifically, this study aims to evaluate the effectiveness of an integrated collaborative care model comprising of a healthcare team (physician, clinical pharmacist, nurse, and/or dietitian) compared to the usual or conventional healthcare model (physician-centered care) mainly in the clinical, humanistic and economic outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients randomly assigned to the control arm will receive the usual or conventional care not interfered by the study team. |
| Intervention | Experimental | Behavioral: collaborative careThe intervention arm will receive collaborative care from a team of healthcare professionals that consists of pharmacist, physicians, nurses and dietitians. Patients in the intervention group will also receive clinical interventions carried out by the pharmacist. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥ 21 years with Type 2 DM (HbA1c > 7%) and polypharmacy (≥ 5 medications) will be eligible for this study.
Key exclusion criteria (1 listed)
- Patients with Type 1 DM or who are unable to communicate independently in English, Chinese or Malay will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collaborative careThe intervention arm will receive collaborative care from a team of healthcare professionals that consists of pharmacist, physicians, nurses and dietitians. Patients in the intervention group will also receive clinical interventions carried out by the pharmacist.nurses and dietitians as well as a pharmacist. | Behavioural | Intervention |
Primary outcome
Change from baseline Body mass index (BMI) at 6-month
Time frame: baseline and 6-month
Change of BMI in kg/m^2
Change from baseline Glycated Haemoglobin (HbA1c) at 6-month
Time frame: baseline and 6-month
Change of HbA1c in %
Changes from baseline Systolic Blood Pressure (SBP) at 6-month
Time frame: baseline and 6-month
Change of SBP in mmHg
Change from baseline Low-density lipoprotein (LDL) at 6-month
Time frame: baseline and 6-month
Change of LDL in mg/dL
Change from baseline High-density lipoprotein (HDL) at 6-month
Time frame: baseline and 6-month
Change of HDL in mg/dL
Change from baseline Total cholesterol (TC) at 6-month
Time frame: baseline and 6-month
Change of TC in mg/dL
Change from baseline Glycerides (TG) at 6-month
Time frame: baseline and 6-month
Changes of TG in mg/dL
Incidence of hypoglycaemia
Time frame: 6-month
Incidence of hypoglycaemia
Change from baseline Body mass index (BMI) at 12 months
Time frame: 12-month
Change BMI in kg/m^2
Change from baseline Glycated Haemoglobin (HbA1c) at 12-month
Time frame: 12-month
Changes of HbA1c in %
Change from baseline Systolic Blood Pressure (SBP) at 12-month
Time frame: 12-month
Change of SBP in mmHg
Change from baseline Low-density lipoprotein (LDL) at 12-month
Time frame: 12-month
Changes of LDL in mg/dL
Change from baseline High-density lipoprotein (HDL) at 12-month
Time frame: 12-month
Changes of HDL in mg/dL
Change from baseline Total cholesterol (TC) at 12-month
Time frame: 12-month
Changes of TC in mg/dL
Change from baseline Glycerides (TG) at 12-month
Time frame: 12-month
Changes of TG in mg/dL
Incidence of hypoglycaemia
Time frame: 12-month
Incidence of hypoglycaemia
17 secondary outcomes
The 5-level EQ-5D version (5Q-5D-5L)
Time frame: baseline
The 5-level EQ-5D version (5Q-5D-5L)
Time frame: 6-month
The 5-level EQ-5D version (5Q-5D-5L)
Time frame: 12-month
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Time frame: baseline
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Time frame: 6-month
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Time frame: 12-month
The Problem Area in Diabetes (PAID)
Time frame: baseline
The Problem Area in Diabetes (PAID)
Time frame: 6-month
The Problem Area in Diabetes (PAID)
Time frame: 12-month
Summary of Diabetes Self-Care Activities (SDSCA)
Time frame: baseline
Summary of Diabetes Self-Care Activities (SDSCA)
Time frame: 6-month
Summary of Diabetes Self-Care Activities (SDSCA)
Time frame: 12-month
Self-report Hypoglycaemia Question
Time frame: baseline
Self-report Hypoglycaemia Question
Time frame: 6-month
Self-report Hypoglycaemia Question
Time frame: 12-month
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
Time frame: 6-month
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
Time frame: 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 28449205Siaw MYL, Ko Y, Malone DC, Tsou KYK, Lew YJ, Foo D, Tan E, Chan SC, Chia A, Sinaram SS, Goh KC, Lee JY. Impact of pharmacist-involved collaborative care on the clinical, humanistic and cost outcomes of high-risk patients with type 2 diabetes (IMPACT): a randomized controlled trial. J Clin Pharm Ther. 2017 Aug;42(4):475-482. doi: 10.1111/jcpt.12536. Epub 2017 Apr 27.
- Background: PubMed 22971205Jarab AS, Alqudah SG, Mukattash TL, Shattat G, Al-Qirim T. Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan. J Manag Care Pharm. 2012 Sep;18(7):516-26. doi: 10.18553/jmcp.2012.18.7.516.
- Background: PubMed 17057049Scott DM, Boyd ST, Stephan M, Augustine SC, Reardon TP. Outcomes of pharmacist-managed diabetes care services in a community health center. Am J Health Syst Pharm. 2006 Nov 1;63(21):2116-22. doi: 10.2146/ajhp060040.
- Background: PubMed 15583361Taylor KI, Oberle KM, Crutcher RA, Norton PG. Promoting health in type 2 diabetes: nurse-physician collaboration in primary care. Biol Res Nurs. 2005 Jan;6(3):207-15. doi: 10.1177/1099800404272223.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Yan Tan principal investigator
National Healthcare Group Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collaborative care in people with Type2 Diabetes, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Body mass index (BMI) at 6-month (time frame: baseline and 6-month). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553862, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.